National Cancer Institute

at the National Institutes of Health

FDA Terminology

The FDA is working with EVS to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by FDA is updated and made available for download from an NCI File Transfer Protocol (FTP) site. FDA terminology subsets are available in each of these four main areas:

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7), an international medical standards organization, and used by FDA to exchange medication information. The SPL standard specifies use of some 30 sets of controlled terminology. The NCI FTP site provides these SPL resources:

NCIt SPL Subsets: Eleven sets of SPL terminology are maintained in NCIt and available for download in Excel or text formats. SPL represents countries with ISO 3166-1 Alpha-3 country codes, extracted from NCIt in separate Excel and text files.

Unique Ingredient Identifier (UNII) codes are being developed by FDA to uniquely identify all ingredients used in marketed medications in the United States, as well as substances in biologics, foods and devices. Each UNII is assigned based on molecular structure or other immutable characteristics. FDA provides a full set of published UNII codes and a search page on a Web site now hosted by the National Library of Medicine (NLM) and updated approximately monthly. These codes are also being included in corresponding NCI Thesaurus concepts, and files providing UNIIs with matching NCI concept codes are available for download in Excel and text formats.

Individual Case Safety Report (ICSR) terminology is used to encode adverse event information for reporting purposes. Fourteen ICSR term sets are maintained in NCI Thesaurus, and are available for download in Excel and text formats.

Global Unique Device Identification Database (GUDID) terminology was developed by CDRH to represent the attributes found in the GUDID, a repository of key device identification information related to a device's Unique Device Identifier (UDI). Labelers wanting to submit their device information using SPL format (and the FDA Electronic Submissions Gateway) will find all necessary codes in this terminology. Through use of the shared document standard, the GUDID terminology may share some codes with the SPL terminology listed separately on this page, but the SPL terminology does not contain all necessary device-related terms for GUDID. The GUDID terminology will be updated as new attributes are developed. The GUDID terminology and codes are maintained in NCIt and available for download in Excel, text and XML formats.